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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02716402
Other study ID # H-15012759
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2015
Est. completion date November 2017

Study information

Verified date August 2018
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to examine previously examined patients with cyanotic congenital heart disease to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.


Description:

Patients with cyanotic congenital heart disease have reduced oxygen content in their blood due to abnormal connection between the heart's right and left sides. The reduced oxygenation of the blood affects several organs of the body and a common complications to the disease is blood clots. Despite the patients are young and do not have typical risk factors, previous studies have shown, that they have a very high prevalence of thrombosis in the lungs and brain.

The reason for the increased prevalence of blood clots is not known. A previous study investigated the prevalence of blood clots systematically in patients with cyanotic congenital heart disease and found that approximately 30-40% of the patients had had a clot in the lung or brain. Thus, the study could not predict, when the patient had had a thrombotic event, and most of the patients did not previously had imaging performed. Therefore the aim of this study is to re-examine previously examined cyanotic patients regardless of previous medical history, to assess how many of the patients have obtained additional blood clots since they were examined 8 years ago.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date November 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria:

- Patients with cyanotic congenital heart disease who have previously participated in the study 'cyanotic congenital heart disease: Hemostatic abnormalities and clinical manifestations' (H-KF-2006-4068).

- Clinically stable

Exclusion Criteria:

- Patients who are not guardians for themselves (not adult).

- Age <18 years.

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
Cerebral MRI and V/Q SPECT/CT
Cerebral MRI and V/Q SPECT/CT

Locations

Country Name City State
Denmark Department of Cardiology, Rigshospitalet Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Annette Schophuus Jensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary and cerebral thrombosis Numbers and locations of cerebral and and pulmonary thrombosis, which will be compared with previous examinations Through study completion, an average of 1 year
Secondary The total numbers of white matter hyper intensity lessons (WMHL) The numbers of WMHL will be compared with previous scans. Through study completion, an average of 1 year
Secondary The size of the white matter hyper intensity lessons (WMHL) The size of the WMHL will be compared with previous scans. Through study completion, an average of 1 year
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